19 days old

Compliance Manager, Quality Control Analytical

Revance Therapeutics Inc.
Newark, CA 94560
  • Job Code
    132437777
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The QC Compliance Manager of analytics will be responsible for compliance of the laboratory operations to internal procedures and regulatory standards ensuring inspection and commercial readiness of the QC operations. Areas of responsibility include but are not limited to the validation of computerized systems, qualification and maintenance of equipment, and management of quality records. Improvement and optimization of laboratory operations including training program to provide a robust and scale-able process that is compliant and efficient will be an area responsibility. All aspects of the role will require active management of the integrity of data.

Essential Duties/Responsibilities
  • Ensure data integrity principles are applied across the organization including identification of gaps and resolution.
  • Oversee the performance and process of Quality Control to assure that product and process meet company, regulatory, and CDC requirements.
  • Identify QC compliance gaps and improvements towards resolution for successful inspectional and audit outcomes.
  • Participate and represent the QC organization in regulatory inspections and internal audits including interfacing with inspectors, as needed.
  • Lead the qualification and maintenance including scheduling of equipment to ensure laboratory operations are maintained with minimal interruptions to business needs.
  • Manage and lead the validation of computerized software or tools within Quality Control in accordance with industry standards, regulatory expectations, and data integrity while assuring business needs are met for the intended use.
  • Manage and maintain the quality records (e.g. laboratory investigations, deviations, change controls, and CAPAs) for Quality Control ensuring on time closure, escalation of issues, and root-cause analysis to identify root cause and improvements.
  • Manage and maintain the training program for Quality Control.
  • Identify and implement process improvements to ensuring efficient management resourcing of staff, laboratory space, etc. in accordance with regulatory expectations and business needs.
  • Supervise and manage staff in support of job responsibilities.


Education

Minimum Required:

BS in Biochemistry, Chemistry or related Sciences

Preferred:

MS in related fields

Experience

Minimum Required:

8+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in QC management or leadership roles

Knowledge, Skills and Abilities

Minimum Required:
  • Proven strong interpersonal, organization and problem-solving skills
  • Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to Quality Control and method validation
  • Experience with technical writing and regulatory requirements for investigative writing as well as quality records.
  • Familiar with regulatory guidance's and requirements (e.g. ICH, USP, WHO, GAMP, etc.) including data integrity
  • Experience in preparing for and participating in regulatory inspections and audits.
  • Experience in identifying issues, driving changes and improvements, and streamlining process.
  • Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment


Preferred:
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
  • Experience with developing and implementation of QC testing programs for biologics drug substance and injectable drug product in a commercial environment
  • Experience with preparing regulatory documentation and inspection management






PI132437777

Categories

Posted: 2021-03-22 Expires: 2021-04-22

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Compliance Manager, Quality Control Analytical

Revance Therapeutics Inc.
Newark, CA 94560

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